Wet floors, unclean play grounds, common bath showers unclean bathtubs are breeding ground for dermatophytes, that cause athletes foot and nail infection. Dermatophytes have ability to invade keratinized tissue (skin, hair, nails) but are usually restricted to non living cornified layers of the epidermis because of their inability to penetrate viable tissue of immunocompetent host. The invasion ranges from mild to severe infection. The causative dermatophytes of nail infection are Trichophyton rubrum or Tmenta grophytes or candida. The nail becomes discoloured and thickens. The thickened nail plate then rises and separates from the nail bed. Fungal infection of the nails besides being a cosmetic problem also has significant psychological, physical and social implications. The incidence of infection of the nail has been on the rise in recent years and is usually treated by topical agents like creams and ointments, which are preferably applied before retiring and are gently massaged into the base of the nail and cuticle.
The management of fungal infection of the nails is carried out by chemical and surgical approach. The formulations available for topical application in form of cream or lotions contain benzoic acid, salicylic acid, imidazole, gresofulvin, zinc undecenoate. Oral supplements such as oral gresofulvin and terbinafine are also recommended.
Topical application based on benzoic acid, salicylic acid and zinc undecenoate has been found to require long term application for four to ten weeks. However, despite this, the recovery is not complete and cases of recurrence have been reported. Moreover, the use of benzoic acid can cause hypersensitivity reactions and is also known to be an irritant to skin, eyes and mucous membrane. Oral grisofulvin and terbinafine hydrochloride supplemented by its topical application has the success rate of 40 to 50 percent but the studies on animal have the evidence that grisofulvin causes toxic effects on liver, thyroid and teratogenicity. Use of terbinafine (5%) both orally and topically, achieves penetration of the keratinizing tissues and success rate is reported to be upto 80 percent. However, common the adverse effects following oral administration are gastrointestinal disturbances, nausea, diarrhoea and headache. Topical reaction causes skin reactions and these adverse effects make the use of this preparation limited.
The present invention improves the drawbacks of the available formulation in the market. The invented formulation is based upon the plant products having synergistic effect hence enhancing the anti-fungal activity with negligible side effects or toxicity. The formulation contains extract from the hulls of Juglans regia. Juglans regia (walnut tree) produces nuts (fruits) covered by green hulls. The green hulls separated from mature walnut contain 50 mg percent of Juglone as reported in paper "Some phytochemical characteristic of Juglans regia, E. Leinberkovics; E. Hethelyi; E. Hetesi; Acta. Pharm. Hung., 1987, V. 57(3-4), 133-142. Besides juglone, it contains 0.4 to 0.8 percent ascorbic acid. Juglone a simple nethoquinone (5-hydroxy-1,4-nethoquinone) has a moderate antifungal activity as reported in paper "Antimicrobial activity of Juglone. A M Clark; T M Jurgens; C D Hufford. Phytotherpy Research. 1990, 4(1), 11-14.
In the paper "Herbal antifungal cream" M V Devi; A. Suneeta, Journal of Research and Education in Indian Medicine. 1993. 12(1), 1-3 (India), dry extracts of whole nut of Juglans regia and Prunus communis have been reported to have antifungal activity against Aspergillus species.